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Electronic Trial Master File eTMF Software

Clinevo electronic Trial Master File (eTMF) is an easy to use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.


Clinevo electronic Trial Master File (eTMF) has inbuilt DIA reference model and meets regulatory guidelines including:

  • Digital Content Archiving, 
  • Security and Access Control, 
  • Change Controls, 
  • Audit Trails and
  • System Validation
Image

Image Inbuilt & Configurable DIA TMF Structure 

  • Clinevo electronic Trial Master File (eTMF) software comes with a prebuilt DIA reference model & also allows organizations to define their own / Sponsor specific TMF structure

Image File Planning & Milestones Setup

  • Clinevo electronic Trial Master File (eTMF) software allows companies to create a File /Study Plan along with milestones at the study level, country level, and site level.​

Image Live Tracking of Missing Documents

  • Based on the file plan, Clinevo electronic trial master file (eTMF) system tracks the status of the documents & monitors the TMF compliance at every level.

Image Document Lifecycle and Version Control

  • Clinevo electronic Trial Master File (eTMF) is one of the best eTMF software which has a robust document lifecycle with Author, Review, eSign/Approval workflow & Automated version controlling with robust Check-in and Check-out functionality

Image Advanced Analytics

  • Clinevo electronic Trial Master File (eTMF) System is the best eTMF that provides advanced analytics to track Completeness, Quality, Timeliness and TMF compliance of a study.

Image Bulk / Quick upload with Dynamic Indexing

  • Clinevo electronic Trial Master File (eTMF) System allows users to upload hundreds of documents in one go using a simple drag and drop & provides dynamic indexing options for documents

Image External Systems Integration

  • Clinevo electronic Trial Master File (eTMF) software is the best eTMF that can be Integrated with CDMS/ CTMS systems to get the study, site, patient and other information and dynamically create Directory structure.

Image Sharing and Collaboration

  • Clinevo electronic Trial Master File (eTMF) System allows users to invite external parties to upload and work collaboratively on documents in a controlled method

Image Faster User Adoption

  • Business TeamS, CROs, Site personnel, External Vendors and others can be trained on the Clinevo electronic Trial Master File (eTMF) System within few hours

Image Anytime, Anywhere & Any device

  • Clinevo electronic Trial Master File (eTMF) System is the best user friendly web application which can be accessed with internet / intranet using IE, Chrome and Firefox browsers.

Image Regulatory Inspection Ready

  • Clinevo electronic Trial Master File (eTMF) System complies with DIA, 21 CFR Part 11, ANNEX 11, GxP and GDPR guidelines.

Image Extendable Document Management System

  • Clinevo electronic Trial Master File (eTMF) System is the best eTMF that can be used as a focused eTMF or as a general document management system for the clinical trials.

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INDIA : +91 - 44 6645 5983

Reach us Now:
info@clinevotech.com

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